Catalog Number

1745

Brand Name

Motion Medical Distributing

Version/Model Number

1745

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

OKV

Product Code Name

Obstetrical Kit

Public Device Record Key

15a18da5-876b-4245-8303-af6f79a0d069

Public Version Date

October 22, 2018

Public Version Number

3

DI Record Publish Date

December 14, 2016

Package DI Number

25060498450335

Quantity per Package

10

Contains DI Package

15060498450338

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case